TMJ FOSSA-EMINENCE/CONDYLAR PROSTHESIS SYSTEM AND TMJ FOSSA-EMINENCE PROSTHESIS
FDA premarket approval P000023/S004 · decided 2003-10-14
Approval details
- PMA number
- P000023
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Other
- Trade name
- TMJ FOSSA-EMINENCE/CONDYLAR PROSTHESIS SYSTEM AND TMJ FOSSA-EMINENCE PROSTHESIS
- Generic name
- Joint, temporomandibular, implant
- Applicant
- Nexus CMF, LLC
- Date received
- 2002-12-26
- Decision date
- 2003-10-14
- Days to decision
- 292 days
- Decision code
- APPR
- Product code
- LZD
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Golden, CO
- Statement
- APPROVAL FOR THE PACKAGING/SHELF LIFE TESTING PROTOCOL TO EXTEND THE SHELF LIFE BEYOND 6 MONTHS.
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